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Hepatitis C Experts Sought for FDA Advisory Committee

SUMMARY: The U.S. Food and Drug Administration (FDA), is looking to add new members with medical expertise and experience in hepatitis C to its Antiviral Drugs Advisory Committee. The committee considers evidence from clinical trials to make recommendations about whether new drugs should be approved. The first of the direct-acting oral hepatitis C agents are in the late stages of testing and will be considered for approval starting next year.

Below is the text of an FDA announcement describing the committee and requirements for prospective members:



FDA Seeking New Members with Hep C Experience
for its Antiviral Drugs Advisory Committee

December 4, 2010 -- The Food and Drug Administration (FDA), to assist in its mission to protect and promote the public health, uses 49 committees and panels to obtain independent expert advice on scientific, technical, and policy matters.

FDA is seeking technically qualified medical/scientific consultants to serve as members of its Antiviral Drugs Advisory Committee for future panels to consider potential direct-acting antivirals (DAAs) for the treatment of hepatitis C -- specifically hepatologists or other medical doctors who treat a substantial number of hepatitis C patients. Consultants should have experience interpreting and analyzing detailed scientific data, and understand its public health significance.

Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. Potential conflicts include, but may not be limited to: employment with a pharmaceutical sponsor, having financial interests or stock in pharmaceutical companies developing DAAs, participating as an investigator in pivotal studies of DAAs in development, being chair of a department in which colleagues are investigating a DAA, or receiving substantial amounts of reimbursement from DAA sponsors for consulting services or presentations.

Advisory Committee meetings are convened in the Washington DC metropolitan area, typically for two days twice a year. Committee members are appointed as Special Government Employees, and receive a salary for each meeting day as well as travel and per diem costs.

General information about FDA Advisory Committees can be found at www.fda.gov/AdvisoryCommittees/default.htm and information about membership can be found at www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/CommitteeMembership/default.htm.

If you are a medical doctor meeting the criteria above, or would like to nominate a medical doctor with hepatitis C expertise, you may submit your information by:

E-mail:
e-mail your information to cv@oc.fda.gov
Mail:
Food and Drug Administration
Advisory Committee Oversight and Management Staff
10903 New Hampshire Avenue, Bldg. 32, Rm. 5101
Silver Spring, Maryland 20993-0002
Please include full contact information of any person you are nominating.

12/10/10

Source
U.S. Food and Drug Administration. FDA seeking new members with Hep C experience for its Antiviral Drugs Advisory Committee. FDA Hepatitis Update. December 4, 2010.


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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